MAUDE Adverse Event Report: BELIMED AG CS 750; CART WASHER

Lot Number	2020060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The component involved in the event is a long thin vertically mounted door frame panel.It is a cosmetic, non-functional component that is attached to the device by several adjustable press-click type fasteners.Device inspection revealed that the clips had not been sufficiently tightened during installation, causing the panel to come loose.The component was reattached and secured by a service technician in accordance with the installation instructions.
Event or Problem Description
While a department worker was unloading the cart washer on the unload side of the unit, one of the vertical trim panels fell and struck the worker in the head.This resulted in the employee receiving a "bump injury" and her seeking medical attention in the er.The injury was deemed to be minor and the employee is doing fine.

• Brand Name: CS 750
• Common Device Name: CART WASHER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 23014094
• Report Number: 3001061128-2025-00006
• Device Sequence Number: 9769822
• Product Code: MEC
• UDI-Device Identifier: 07640141626054
• UDI-Public: (01)07640141626054(11)240404
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Lot Number: 2020060
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown